Catalog Number

-

Brand Name

Centurion

Version/Model Number

MNS12085

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MLS

Product Code Name

Labor and Delivery Kit

Public Device Record Key

d9020449-cbd4-43b3-a7be-d0a0457faf12

Public Version Date

April 19, 2019

Public Version Number

1

DI Record Publish Date

April 11, 2019

Package DI Number

00653160325942

Quantity per Package

5

Contains DI Package

10653160325949

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE